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Regulatory Affairs Specialist 5484

  • Job reference: 934102
  • Location: Maidenhead, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 16/02/2021

Orion Group Life Sciences have an exciting opportunity for a Regulatory Affairs Specialist for our Multinational Medical Client based in the Berkshire area on an initial 6-month contract

Job Purpose:

  • Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
  • Supports the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfolio range.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
  • Responsible for regulatory activities related to National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Define regulatory strategies (local and regional) in line with business plan.
  • Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions (Marketing Authorisations Applications, Renewals Variations, and Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.
  • Sign off packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions
  • Ensure Marketing Authorisations are maintained and renewed, and sunset obligations are met
  • Ensures compliance within the department by ensuring
    - Global, EAME and local databases are fully maintained.
    - Processes, SOPs, working instructions and Job Aids are adhered to.
    - Update relevant local and global databases to track current product information.
    - Supports the Northern Europe Regulatory team by assisting in any Pharmacovigilance related activities:
  • Receive and monitor responses to Calls for Information (CFI) through liaison with UK and EAME colleagues.
  • Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the department and functional policy
  • Provide support with responses to ad hoc requests received from UK PV group or Global functions.
  • Ensure RA obligations are met in line distributor agreements with third parties (as appropriate).
  • Good Regulatory Practice
  • Maintain awareness/knowledge of current regulatory guidance and legislation, in particular related to Brexit
  • Always ensures regulatory best practice.
  • Ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
  • Represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
  • Interactions with Regulatory Agency
  • Provides regulatory guidance to internal stakeholders, to allow them to make key decisions on business-critical activities and project feasibility.
  • Develop product and therapeutic area knowledge as needed.
  • Ensure that any processes or SOPs/working instructions/ job aids roll outs are actioned in Compliance Wire (Training System) and within the defined timeline.
  • Maintains training record (as appropriate).

Desired Experience and Background of the successful candidate

  • Life sciences or chemistry graduate to honours level or equivalent.
  • 5+ years' experience in a similar role
  • Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience
  • Brexit related regulatory knowledge and experience
  • Must have hands on experience in management of day to day UK and EU regulatory procedures
  • Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity including processes
  • Project management, understanding of regulatory environment, and interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, and implement regulatory strategy, managing and maintaining Marketing Authorisations etc.

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 or email Denise.Cagney@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 934102


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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